Mobile medicine apps are the future, as we move increasingly into digital, virtual communication; yet FDA medical device and other legal issues remain.

Recently it was reported thateverything in medicine in going mobile:

Cardiologist Eric J. Topol, MD, was on a cross-country flight when an attendant made an announcement asking if there was a doctor on board.

Dr. Topol, chief academic officer for Scripps Health, responded and was brought to a man who was in obvious trouble. Only a year or two ago, Dr. Topol would have had to make an educated guess and hope he could take care of the patient until the plane landed.

This time, though, he pulled out his iPhone, and with an app that produces an electrocardiogram, he determined that the patient was having a heart attack. The plane made an emergency landing while paramedics waited on the ground to take the patient directly to surgery to open the blocked arteries causing the attack.

Though the story is an extreme example, it illustrates why mobile technology was such a big focus of the 2012 annual meeting of the Healthcare Information and Management Systems Society, where Dr. Topol shared the story. With each passing day, mobile technology is giving physicians more opportunities to practice medicine from anywhere, at any time....

Mobile technology is bringing the patient’s bedside to the physician’s smartphone or tablet computer.....

Just a few years ago, physicians with patients in hospitals either had to be at the patient’s bedside to get a complete view of what was going on or rely on a floor nurse’s interpretation of what the patient’s monitoring devices showed.

Mobile technology has made it possible to bring the patient’s bedside to the physician’s smartphone or tablet.

Applications can send a physician real-time updates on a patient’s condition regardless of where the physician is. A doctor can monitor the wave-forms of cardiac monitors, contraction and fetal monitors, ventilators, and a host of other bedside monitors. A dashboard displays a patient’s vitals and lab values, and all the information from the patient’s electronic health record can be accessed from a device small enough to fit in a pants pocket.

 If you are fan of Ray Kurzweil, who wroteThe Age of Spiritual MachinesandThe Singularity Is Near, you'll recognize this scenario: from Web to mobile to implants in our bodies - tiny nano robots that monitor our health and give us instantaneous boosts and repair.  The emphasis on mobile medical technology is a way-station to that reality.

FDA and other legal and regulatory issues, however loom.

Recently, for example, the FDA announced that when cellphones are used as medical devices, they are subject to legal rules and regulation governing medical devices.  Smart phone?  Smart FDA.

Telemedicine and legal rules governing corporate practice of medicine and unlicensed medical practice also may apply. For example, see:

• Corporate practice of medicine doctrine varies by state and by prohibition
• Telemedicine, Telepsychology, Telepsychiatry and Telehealth Legal Issues
• Telemedicine legal exceptions require careful scrutinty
• Telemedicine laws vary by state
• Telemedicine Legal Issues
• Online Health Services and Products (FDA and FTC Legal)

Intellectual property concerns, including copyright, trademark, and patent, also will be important.

If you are developing a mobile medical application (app) or a device for e-health, be sure to consult with an attorney familiar with Food and Drug Administration laws governing medical devices, Federal Trade Commission rules governing advertising, state medical licensing and telemedicine rules, and other areas of law and regulation.

Many entrepreneurs want to know whether their invention is a medical device, a drug, a cosmetic, a biologic, or otherwise FDA-regulated.

Cosmetics v. Drugs

Let's start with some basic definitions:

TheFederal Food, Drug, and Cosmetic Act(FD&C Act) and the federal Food and Drug Administration (FDA) define products by theirintended use.

• Cosmetics are"articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. According to theFDA, among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.
• The FD&C Act defines drugs, in part, by their intended use, as"articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and"articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

The FDAstates:

Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

According to the FDA, intended use can be shown by:

• Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials.
• Consumer perception, which may be established through the product's reputation.
• Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use.

Thus, certain claims"may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic....Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells."

An example where ingredients cause the product to be considered a drug, is fluoride in toothpaste.

The FDA has different labeling requirements for drugs and cosmetics.

• Approval requirements for drugs vs. cosmetics: there is no premarket approval system for cosmetic products or ingredients (with the exception of color additives).
• Drugs usually must receive premarket approval by the FDA or conform to final regulations that specify conditions where they are generally recognized as safe and effective,but not misbranded.  (There are separate rules for over-the-counter (OTC) drugs).
• Good manufacturing practices (GMPs) are different: there are strict GMP requirements for drugs and none for cosmetics (other than ensuring that the products are neither adulterated nor misbranded. However, no regulations set forth specific GMP requirements for cosmetics.
• FDA maintains theVoluntary Cosmetic Registration Program⁷, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207].
• Labeling requirements are different. The FDA has a Cosmetic Labeling Manual for guidance on cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the"Drug Facts" labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as"Active Ingredients," followed by cosmetic ingredients, listed in order of predominance as"Inactive Ingredients."

The FDA has a webpage that serves as a portal for regulatory information regardingFDA regulation of drugs.

Included is information aboutdrug applicationsfor over-the-counter (OTC) drugs.  The FDA states:

Because there are over 300,000 marketed OTC drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids,  instead of individual drug products.  For each category, an OTC drug monograph is developed and published in theFederal Register.  OTC drug monographs are a kind of"recipe book" covering acceptable ingredients, doses, formulations, and labeling.  Many of these monographs are found insection 300 of theCode of Federal Regulations¹.  Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval.  New prescription drugs, on the other hand, require pre-approval before they can go on the market.  These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients.   New products that conform to a final monograph may be marketed without further FDA review.  Those that do not conform  must be reviewed by theNew Drug Application²process.  A drug company may also petition to change a final monograph to include additional ingredients or to modify labeling.

According to the FDA, 6 out of 10 drugs are OTC drugs.

Medical Devices

The first thing is to determine if you have a medical device.  The FDA notes that the definition of medical devices is verybroad:

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronicradiation emitting products³with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug& Cosmetic (FD&C) Act it will be regulated by theFood and Drug Administrationas a medical device and is subject to premarketing and postmarketing regulatory controls.

A medical device is"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

The FDA has a wealth of information to consider before marketing a medical device on its FDA webpage dedicated tomedical device regulation.

Medical Device v. Drug

The FDA notes that the difference between a medical device is its intended use: if the intended use is through chemical action or being metabolized by the body, the product is usually a drug.

Note that the FDA regulates drugs through its Center for Drug Evaluation and Research (CDER), but regulates biological products and blood banking equipment through its Center for Biologics Evaluation and Research, and veterinary products through its Center fo Veterinary Medicine (CVM).

If you have a medical device, the next thing is to determine itsdevice classification(i.e., whether it is Class I, Class II or Class III), and whether your device is"substantially equivalent" (SE) to an already legally marketed medical device that is not subject to premarket approval (PMA).  You determine this by filing a 510(k) submission to the the FDA to demonstrate substantial equivalence.

There are two powerful ways to begin to research substantial equivalence, in preparation for the 510(k) submission:

Search the 510(k) Medical Device Classification Database

Search the Device Classification Panelsin the Code of Federal Regulations (CFR)

Devices are organized in 21 CFR, Parts 862-892 into 16 medical specialty panels, such as anesthesiology, cardiovascular, chemistry, dental, ear nose and throat, gastroenterology and urology, general and plastic surgery, immunology, microbiology, and so on.

For Class I devicesexemptfrom [510(k)] the submission of a [510(k)] and marketing clearance from FDA is not required. If your Class I (or certain class II) device is exempt, subject to the limitations on exemptions, from the510(k)process, this will be stated in the classification regulation. However, other General Controls such asregistration and listing,labeling, andgood manufacturing practicesapply. If you have a Class III device requiring premarket approval (PMA) the FDA has guidance on obtaining a PMA.

Dietary Supplements

The term"dietary supplement" was defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994. The FDAstates the definitionfor consumers as follows:

A dietary supplement is a product taken by mouth that contains a"dietary ingredient" intended to supplement the diet. The"dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of"foods," not drugs, and requires that every supplement be labeled a dietary supplement.

The FDA provides severalguidance documentsfor industry professionals seeking assistance with labeling, claims, substantiation, and other regulatory issues.

If you have a product and are unsure whether it might be regulated by the FDA as a cosmetic, drug, medical device, dietary supplement (or food), biological, or otherwise, the FDA website is a good place to start.  You should also contact an experience FDA attorney to help you create legally compliant labeling, advertising, and marketing materials for your product.  Ourlaw firmhas FDA expertise and can help provide legal guidance for you from concept to market.

A federal judge recently held that the disclaimer required by the FDA for a qualified health claim about green tea and the risk of cancer is so strongly worded that it“effectively negates” the manufacturer’s claim.

Note that the case involves a qualified health claim (QHC) and not the typical structure / function claim that people at Whole Foods or other health food stores typically see on the dietary supplement label. The QHC isdifferentin that:

QHCs enable companies to make a health claim about a substance in relation to a disease or condition when the supporting science fails to meet the FDA’s“significant scientific agreement” standard, so long as that health claim is“qualified” in such a way as to not mislead consumers....

In practice, however, FDA rarely approves QHCs: the agency approvedonly twelve QHCsbetween 1999 and September 2010—and when they did, they usually created disclaimers that completely reversed the meaning of the claim. It was because of this thatANH-USA sued the FDAover its treatment of the QHC for selenium and cancer. And we were successful in creating a precedentthat restricts FDA’s ability to infringe on the right to free speech, a right that is at least in part provided by QHCs.

Fleminger, Inc., sells green tea at TeaForHealth.com and discussesthe science of antioxidants and the research on green tea’s anti-cancer properties. Fleminger first submitted a health claim petition to FDA in 2004. A year later, the FDA proposed two disclaimers that stated, in part,“FDA concludes that it is highly unlikely that green tea reduces the risk” of breast cancer or prostate cancer. Fleminger petitioned for an administrative review but it was denied.

In 2010,FDA sent a warning letter to Fleminger threatening to seize its products and insisting it use the exact language set forth in its qualified health claims. Shortly thereafter, however, FDA proposed a revised claim:“Green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.” This prompted Fleminger’s suit in the US District Court, asserting that FDA was making Fleminger“choose between speaking exactly as [FDA] wishes, remaining silent, or risking adverse action for its own commercial speech in violation of the First Amendment.”

Judge Bryant agreed with Fleminger: The FDA’s language“effectively negates the substance–disease relationship claim altogether….There are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.”

According to a U.S. GAO document entitledFood Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims-

 FDA is responsible for ensuring the proper labeling of food, and the use of structure/function claims is subject to the general statutory requirement that labeling not be false or misleading. However, FDA has not given companies guidance on the scientific support needed to prevent false or misleading information in a structure/function claim for food. FDA has guidance for the dietary supplements industry on the scientific support needed to prevent false or misleading information for a structure/function claim for dietary supplements...

The GAO compares FDA and FTC authority to the regulatory system used in the European Union:

Unlike FTC, which may require companies to provide the evidence to support their advertising claims, FDA bears the burden of proving that a structure/function claim is false or misleading without having the authority to compel companies at the investigation stage to produce the evidence that the companies assert as support for their advertising claims. According to senior attorneys in FDA’s Office of the Chief Counsel, FDA’s efforts to meet that burden are hampered by the lack of access to the evidence that a company relies on to make such a claim. In particular, while FDA may ask a company to provide its evidence, FDA does not have express legal authority to compel the company to provide information. To support an action, FDA may need to review the scientific literature to determine whether the literature supports a claim—an effort that may be time consuming and labor intensive. FDA may also need to establish through research how consumers perceive the claim. If the structure/function claim, or any claim for that matter, is one for which there is little publicly available information, it can be difficult for FDA to develop the evidence needed to support an enforcement action. It also can be difficult to evaluate the support for a structure/function claim when the functions, such as“immunity” or“attention,” do not have generally established measures for the claimed benefit. For example, it is not necessarily clear what outcome measures would be a valid means of assessing whether a food“improves vitality.”

Furthermore, in contrast to the United States, the EU follows a different course: EU Commission officials told us the responsible EU food agency must preapprove the type of food claims that FDA calls structure/function claims before they can be used. EU Commission officials also stated that their scientific review agency rejected 85 percent of structure/function claims companies have submitted because of the lack of scientific support. Canada is also reviewing structure/function claims food companies have submitted by developing a list of approved claims; it too has rejected most claims, including some found on labels in the United States, according to a Canadian official. To protect the public from false or misleading claims, the Canadian food labeling agency is working with the Canadian agency that regulates advertising to develop a framework for regulating structure/function claims.

The above is positive in terms of pushback against the FDA from a free speech perspective, though again, it deals with qualified health claims and not structure/function claims. 

Qualified health claims are health claims that characterize the relationship of a food component to a disease or health-related condition, as modified with a disclaimer or otherwise qualified by FDA to characterize the strengths and limitations of the scientific support to address the claim’s potentially misleading nature. For example, the following is a qualified health claim allowed by FDA characterizing the relationship between the consumption of tomatoes and the risk of gastric cancer:1“Four studies did not show that tomato intake reduces the risk of gastric cancer, but three studies suggest that tomato intake may reduce this risk. Based on these studies, FDA concludes that it is unlikely that tomatoes reduce the risk of gastric cancer.” Qualified health claims for food are not provided for in statute. Instead, they came about as a consequence of FDA’s decisions following a 1999 federal appeals court ruling (Pearson v. Shalala). The court held that the First Amendment does not permit FDA to prohibit a potentially misleading health claim on a dietary supplement label unless FDA considers whether qualifying language on the label could negate the potentially misleading nature of the claim. (Dietary supplements are products that contain certain dietary ingredients such as vitamins, minerals, or herbs, intended to supplement the diet, and are labeled as dietary supplements.)

Notesone commentator:

The FDA still has authority to regulate structure / function claims and may treat them as disease claims if they reference an underlying disease or condition (such as obesity or diabetes, for example).  Note that there are also FDA and FTC substantiation requirements with regard to structure / function claims, even though not as strict as for QHCs.

If you are involved in manufacturing or distributing dietary supplements or other natural products, be sure to contact an experienced health care lawyer who is familiar with the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) review of dietary supplement claims and labels.

Contactour legal teamtoday.